Zenbexus-led combination nabs FDA’s first CELMoD therapy approval in multiple myeloma

A U.S. appeals court revived a lawsuit by Celgene shareholders against Bristol Myers Squibb over Breyanzi’s late FDA approval and a CVR tied to $9 per share. The court said a 2024 dismissal was wrong on trustee jurisdiction, citing acceptance of UMB Bank as trustee. The dispute stems from BMS’s 2019 Celgene $74B deal and a potential $6.4B payout.

Bristol Myers Squibb said the FDA granted its first approval for the CELMoD therapy Zenbexus (iberdomide) for previously treated multiple myeloma in combination with Johnson & Johnson’s Darzalex and dexamethasone. Approval is accelerated using MRD as a surrogate endpoint. In Excaliber-RRMM, MRD-negative response was 41% vs 21% with a Darzalex plus Velcade regimen; PFS remains a confirmatory endpoint.

The US FDA granted accelerated approval to Bristol Myers Squibb’s iberdomide (Zenbexus) for relapsed or refractory multiple myeloma in combination with Janssen’s Darzalex and dexamethasone. Bristol said the approval is based on a planned analysis showing improved minimal residual disease versus standard therapy. Zenbexus carries a boxed embryo-fetal toxicity warning and restricted distribution; list price is $29,500 per 28-day cycle.

Bristol Myers Squibb (BMY) said the FDA approved Zenbexus (CELMoD) for relapsed/refractory multiple myeloma in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for patients after at least one prior therapy line. Approval follows Phase 3 EXCALIBER-RRMM results, with MRD-negative complete response 41% vs 21% at median 16 months. Breakthrough Therapy and accelerated approval apply; full approval depends on confirmatory trials.

Bristol Myers Squibb said the FDA granted accelerated approval for Zenbexus (a CELMoD) in multiple myeloma, for patients previously treated with a proteasome inhibitor and an immunomodulatory agent. Approval followed Phase III EXCALIBER-RRMM results versus daratumumab, bortezomib and dexamethasone, with MRD-negative complete response at 41% vs 21% at 16 months. Safety included 4.9% fatal adverse reactions.

The FDA granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) with daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma after at least one prior therapy line. Full approval depends on confirmatory trials. In Phase III Excaliber-RRMM, MRD-negative complete response was 41% vs 21% at median 16 months.